The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Wz Self-expanding Stent Transhepatic Biliary System.
| Device ID | K031331 |
| 510k Number | K031331 |
| Device Name: | WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
| Contact | Joanna Kuskowski |
| Correspondent | Joanna Kuskowski ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-28 |
| Decision Date | 2003-08-12 |
| Summary: | summary |